At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 417 enrolled
Drug / intervention
HX575 epoetin alfa (Sandoz)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
In Brief
A Phase 3 clinical trial evaluating HX575 epoetin alfa (Sandoz) for Chronic Kidney Disease. Completed, enrolled 417 participants across 50 sites in 7 countries.
Detailed Summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesGermany, Italy, Poland, Romania, Russia, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionOct 2014
Study CompletionJun 2015
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartApr 1, 2012
Primary CompletionOct 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.2 years ago
Interventions
HX575 epoetin alfa (Sandoz)drug
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.